Implantable fluid transfer system

ABSTRACT

Surgical implants and procedures for restoring erectile function are described.

CROSS REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to U.S. ProvisionalApplication Serial No. 60/380,684, filed May 12, 2002.

BACKGROUND

[0002] The present invention relates to medical devices used in implantsurgery. More specifically, the present disclosure relates to aninflatable penile prosthesis assembly, or penile implant.

[0003] Even as late as the early 1970's, the conventional view ofimpotence was that ninety percent of cases were psychologically based,whereas only ten percent of the cases were caused by a physicalcondition. Today, doctors and scientists understand that theoverwhelming majority of cases are caused by a physical condition.According to a recent study, fifty-two percent of men between the agesof forty and seventy self-reported that they suffer from some type oferectile dysfunction. Another study estimated that over thirty millionAmerican men and their partners suffer from erectile dysfunction.

[0004] Advertisements for pharmaceutical treatments for impotence havebecome ubiquitous. More and more men and their partners now are seekingtreatment for impotence. In the recent past, it was estimated that onlyone in twenty sufferers of erectile dysfunction sought treatment fromtheir doctors. Pharmaceutical treatments are successful for only asubset of impotence sufferers. Other treatments, including more invasivetreatments are necessary for many men. These treatments includeinjection therapy, vacuum devices and penile prosthesis.

[0005] Penile implants are disclosed in U.S. Pat. Nos. 3,853,122;4,009,711; 3,954,102; 4,537,183; 4,566,466; 3,987,789, 4,350,151;5,788,627; 4,651,721; 5,141,509; 5,851,176; 5,167,611; 6,443,887 and6,533,719. Commercial examples of penile prosthesis include the AMS 700CX™ and the AMS 700 Ultrex™ available from American Medical Systems ofMinnetonka, Minn. and the Mark II Inflatable Penile Prosthesispreviously available from Mentor of Santa Barbara, Calif. The Mark IIprosthesis included an injection port in a resipump element.

[0006] The penile implant has been used for decades and provides aselected and reliable erection. Inflatable penile implants typicallyinclude a pair of cylinders. In some instances, these cylinders areconnected to a fluid-filled reservoir with a pump and valve assembly.The two cylinders are normally implanted into the corpus cavernosae ofthe patient's penis and the reservoir is typically implanted into thepatient's abdomen. The pump assembly is implanted in the scrotum. Duringuse, the patient actuates the pump and fluid is transferred from thereservoir through the pump and into the cylinders. This results in theinflation of the cylinders and produces rigidity for a normal erection.Then, when the patient desires to deflate the cylinders, a valveassembly within the pump is actuated in a manner such that the fluid inthe cylinders is released back into the reservoir. This deflationreturns the penis to a flaccid state.

[0007] A type of inflatable penile implant includes one or morecylinder(s) having inflation chamber(s) that are disposed within thepenis (corpus cavernosae). The penile implant includes a remote pumpassembly that is connected via tubing to the cylinder(s). The tubing isconnected to the cylinder(s) at tubing junction(s). In prior artexamples, such as those in United States Patent Nos. among others, showa straight bore extending through the strain relief and into theinflation chamber. Fluid is transferred from the pump assembly, throughthe tubing, and into the cylinder(s).

[0008] Prior art methods for implanting inflatable prostheses typicallyincluded the step of leaving the cylinders inflated or partiallyinflated in the immediate post operative period. This allows the tissuesurrounding the cylinder to heal while the cylinder is in an inflatedcondition. However, in systems that include a balloon like reservoir,this meant that the balloon-like reservoir was in a deflated orpartially empty condition. In the prior art procedures, the body healedwith the reservoir in such a condition. Unfortunately, scar tissue canform that can result in discomfort or pain when the reservoir wasthereafter filled. It is also believed that the scar tissue can causethe cylinder(s) of the system to partially inflate at unintended timesor prevent the cylinder(s) of the system from completely deflating.

[0009] U.S. Pat. No. 5,250,020 discloses a unitary inflatable penileprosthesis. This prosthesis includes an injection port with flexiblesilicone rubber. The injection port is said to be capable of partiallyprefilling the prosthesis at the time of manufacture, thereby relievingthe surgeon of the task of assembling the components at the time ofimplantation.

[0010] U.S. Pat. No. 4,766,889 discloses an infusion erectile system.The system includes a septum and reservoir.

[0011] Some patients or surgeons complain of penile shaft shorteningand/or insufficient cylinder flaccidity following penile implantationsurgery. Although rare, some penile implants become infected and leaksin the hydraulic system develop in some.

SUMMARY OF THE INVENTION

[0012] In one aspect, the present invention comprises a septum in aninflatable penile prosthesis system that affords post-operative periodaccess to the interior of the system. This allows both the reservoir andcylinders to be in a filled condition in the immediate post operativeperiod.

[0013] According to one embodiment, the present invention comprises amethod of restoring erectile function comprising the steps of: i)providing an inflatable penile prosthesis system comprising a pump, atleast one and preferably two cylinders capable of inflated and deflatedstates, a septum and a reservoir capable of inflated and deflatedstates; ii) providing sufficient fluid to inflate the cylinder(s) andthe reservoir to the inflated condition; iii) implanting the inflatablepenile prosthesis system with the cylinder(s) and reservoir in theinflated condition; iv) leaving the cylinder(s) and reservoir in theinflated condition in the immediate post operative period, and v)thereafter inserting a needle through the septum and withdrawing somefluid from the inflatable penile prosthesis system. Preferably, the stepof leaving the cylinder(s) and reservoir in the inflated condition inthe immediate post operative period includes the step of leaving thecylinder(s) and reservoir in the inflated condition for at least threedays, more preferably at least seven days.

[0014] In another aspect, the invention comprises a method of detectingan unsatisfactory condition of an inflatable penile prosthesis systemcomprising a pump, cylinder(s), fluid circuit, a septum and a reservoir.The method comprises the steps of: i) implanting the inflatable penileprosthesis system in a patient; ii) providing a probe assembly withfirst and second sensors; iii) placing the first sensor through theseptum and into the fluid circuit of the inflatable penile prosthesissystem; iv) placing a second sensor outside the penile prosthesis systemin the patient's tissue, v) sensing conditions with the first and secondsensors, and vi) comparing the conditions sensed by the first and secondsensors to detect an unsatisfactory condition. The unsatisfactorycondition may comprise fluid leakage or infection. The first and secondsensors may be capable of sensing pH, electrical resistance orelectrical potential. In the later case, the probe system may comprisean ohmmeter. In a preferred embodiment, at least one of the first andsecond sensors is integrated into the inflatable penile prosthesissystem, and the probe system includes means for communicating with thesensor integrated into the inflatable penile prosthesis system.

[0015] In another aspect, the present invention comprises a system forrestoring erectile function comprising a pump, cylinder(s), tubing and areservoir, a fluid circuit within the system containing fluid, a septum,and an antimicrobial or antibiotic within the fluid placed by insertinga needle through the septum and injecting the antimicrobial orantibiotic. For example, the antimicrobial or antibiotic may compriserifampin and minocycline. Alternatively, an antimicrobial may comprisean iodine containing compound.

[0016] In yet another aspect, the present invention comprises a methodof restoring erectile function comprising the steps of: implanting aninflatable penile prosthesis having fluid and a septum, placing a needlethrough the septum, and injecting an antimicrobial through the septumand into the prosthesis. In a preferred embodiment, the prosthesiscomprises cylinder(s) comprising silicone, and the antimicrobialcomprises iodine. Preferably, the method further includes the step ofaspirating fluid from the inflatable penile prosthesis prior to the stepof injecting an antimicrobial. Alternatively the antibiotic solution maybe infused.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Other features and advantages of the present invention will beseen as the following description of particular embodiments progressesin conjunction with the drawings, in which:

[0018]FIG. 1 is a schematic view of a three piece embodiment of thepresent invention showing a pump bulb and a fluid septum;

[0019]FIG. 2 is an enlarged sectional view of a portion of the pump bulband septum of FIG. 1;

[0020]FIG. 3 is a side view of the components of FIG. 2;

[0021]FIG. 4 is a schematic view of another three piece embodiment ofthe present invention showing a fluid septum in a location differentthan that of the embodiment shown in FIG. 1;

[0022]FIG. 5 is an end view of the embodiment of FIG. 4;

[0023]FIG. 6 is a side view of a two piece embodiment of the presentinvention;

[0024]FIG. 7 is a schematic view of a component of a probe assemblyaccording to an aspect of the present invention;

[0025]FIG. 8 is a schematic view of the probe of FIG. 7 being insertedinto the septum of FIG. 1; and

[0026]FIG. 9 is a schematic view showing a probe assembly and portionsof a penile prosthesis assembly according to an aspect of the presentinvention.

DETAILED DESCRIPTION

[0027] The following description is meant to be illustrative only andnot limiting. Other embodiments of this invention will be apparent tothose of ordinary skill in the art in view of this description.

[0028] Referring now to FIGS. 1, 2 and 3, there is shown components ofan inflatable penile prosthesis system suitable for use in a methodaccording to the present invention. The system 10 comprises a pump (e.g.a pump bulb 12), at least on and preferably two cylinders 16 capable ofinflated and deflated states, septum 20 and reservoir 18 capable ofinflated and deflated states. Suitable cylinders, pumps and reservoirsare disclosed in U.S. Provisional Patent Application No. 60/453,684 andpublished U.S. Pat. Application Nos. 2003/0065249A1; 2003/0028076-A1;2002/0091302-A1; 2002/0082709-A1; 2002/0082708-A1; 2002/0082473-A1; and2002/0082471-A1; and U.S. Pat. Nos. 6,346,492; 6,443,887 and 6,558,315.

[0029] As used herein, a septum 20 is an article constructed from abiocompatible (preferably non-porous) material that can be piercedrepeatedly without leaking fluids or bacteria. Soft silicone rubbers arebelieved suitable for such products. Suitable materials includesilicones, rubbers, polymers and combinations thereof. Commercialexamples include Nusil 4750 silicone, Nusil 4735 and Nusil 4720silicones available from Nusil of Carpenteria, Calif. In a preferredembodiment, the septum 20 is replaceable so that it could be replaced(e.g. during a revision surgery). Alternatively, the septum 20 maycomprise a permanent septum.

[0030] Preferably the septum is sized and shaped to afford access to theinterior of the prosthesis without unduly irritating tissue. Forexample, the septum may be between 4 and 8 mm in diameter with a heightof between about 3 and 5 mm. Alternatively, the septum may besufficiently large to act as a pump for pumping fluid or creatingpressure surges. In an alternative embodiment, the septum may be used toactivate a system. The device could remain inflated for a specificperiod of time and then become deactivated through the same septum orwould gradually deflate by accelerated osmosis or a calibrated leak paththat affords slow leakage over time. Fluid could be absorbed by the bodyor vascular system. Optionally, activation could be through atranscutaneous port that that includes a septum and which leads to thedevice via tubing.

[0031] In another embodiment, the septum may be placed on the interiorof the pump bulb 12 or include shielding to reduce the chance ofinadvertent damage to the prosthesis or positioning probes.

[0032] The system may be used in a method of restoring erectilefunction. The method generally includes the steps of i) implanting asystem that is overfilled with fluid to inflate both the reservoir andthe cylinder(s), ii) waiting until the body has sufficiently healed, andiii) then removing excess fluid. The method comprises the steps of:providing the inflatable penile prosthesis system 10; providingsufficient fluid to inflate the cylinder(s) 16 and the reservoir 18 tothe inflated condition; implanting the inflatable penile prosthesissystem 10 with the cylinder(s) and reservoir in the inflated condition;leaving the cylinder(s) 16 and reservoir 18 in the inflated condition inthe immediate post operative period, and thereafter inserting a needlethrough the septum 20 and withdrawing some fluid from the inflatablepenile prosthesis system. Preferably only the excess fluid is removedafter healing, leaving the optimum amount of fluid in the system. Alsopreferably, the step of leaving the cylinder(s) and reservoir in theinflated condition in the immediate post operative period includes thestep of leaving the cylinder(s) and reservoir in the inflated conditionfor at least three days, more preferably at least seven days.

[0033] The septum 20 allows the surgeon to leave both reservoir 18 andthe cylinder(s) 16 fully inflated in the immediate post operativeperiod, allowing the body to heal in the best possible configurationwith a fully extended capsule around the cylinder(s) 16 and a full sizecapsule around the reservoir 18. Preferably, the reservoir 18 andcylinder(s) 16 remain in the fully inflated condition at least two daysfollowing the surgical procedure and more preferably at least three. Theamount of time period may vary due to a variety of factors such as thecondition of the particular patient, the presence of concomitantprocedures and the ability to schedule a follow up visit and the like.In some cases, seven days may be desirable.

[0034] Preferably, the surgeon implants the system with the cylinder(s)16 left nearly fully inflated in the post operative period. It isbelieved that such a step would reduce the chances of hematoma and allowthe capsule around the cylinder(s) and reservoir to form at a fullydistended condition. It is also believed to maintain penile shaft lengthfollowing surgery. Following a time period, the surgeon uses the septum20 to remove fluid from the system to the point of satisfactoryflaccidity.

[0035] Should the reservoir 18 ever become encapsulated with significantscar tissue, the septum 20 allows the surgeon to fill the cylinder(s) 16and the reservoir 18 and allow the power provided by the cylinder(s) 16to gradually distend the capsule of the reservoir 18. The surgeon couldexploit the additional fluid in the cylinder(s) 16 to force fluid backinto the reservoir 18, again leaving the cylinders 16 fully inflated toallow capsule formation at the greatest diameter of the reservoir 18.

[0036] With the septum 20, fluid may be added or removed from thehydraulic system without disconnecting and reconnecting components (e.g.tubing). The septum 20 could also be used if needed to add fluid to asystem where additional fluid requirements emerged over time. Forexample, this may occur where the shaft length and cylinder volumerequirements change with time and the initial reservoir was insufficientto accommodate the change. Such occurrence can occur in patients withsignificant scarring from disease processes or previous surgery.

[0037] The present invention contemplates that the septum may be placedin a variety of different locations. Referring to FIGS. 4 and 5, thereis shown another embodiment of system 40 according to the presentinvention. The system 40 includes cylinder(s) 36, reservoir 38, pumpwith pump bulb 32 and a septum 50. The septum 50 is located on the sideof the pump assembly instead of in the walls of the pump bulb (as shownin FIG. 1). Alternatively, the septum may be located on a cylinder.While one septum is preferred, a plurality of septums, at differentlocations, may also be employed in accordance with the presentinvention.

[0038] The present invention may be utilized in both two piece and threepiece penile prosthesis systems. FIG. 6 illustrates a two piece systemcomprising inflatable cylinder(s), an inflatable pump bulb 74 and aseptum 76. Having a septum 76 on a two piece system affords fullydistended capsule formation on the proximal corporal reservoir.

[0039] In another embodiment, the septum 20 affords a method ofinjecting an antibiotic or antimicrobial solution into the device forthe treatment of device infection with standard antibiotics or otherproprietary treatment methods. The invention comprises a system forrestoring erectile function comprising a pump, cylinder(s), tubing and areservoir, a fluid circuit within the system containing fluid, a septum,and an antimicrobial or antibiotic within the fluid placed by insertinga needle through the septum and injecting the antimicrobial orantibiotic. For example, the antimicrobial or antibiotic may compriserifampin and minocycline. Suitable antimicrobials or antibiotics aredisclosed in U.S. Pat. Nos. 5,624,704; 5,756,145; 5,902,283, 6,162,487and 6,534,112.

[0040] Alternatively, an antimicrobial may comprise an iodine containingcompound. This would avoid opening and remaking a connection or, as isoften necessary, addition a piece of tubing and adding new connectors.

[0041] Referring now to FIGS. 7 and 8, the septum 20 affordspost-operative confirmation of device complications (e.g. such asleakage or infection). In another aspect, the invention comprises amethod of detecting an unsatisfactory condition of an inflatable penileprosthesis system (e.g. 10) comprising a pump 12, cylinder(s), fluidcircuit, septum 20 and a reservoir.

[0042]FIG. 7 shows a sensor 71 including a non-coring needle orneedle-like structure 73 (e.g. of conductive material) for traversingthe septum, a non-coring tip 75, a non-conducting shaft 77 and a lumen79 for adding or withdrawing fluid. The shaft 77 has an insulating ornon conductive coating or surface on all or most of the exterior of theneedle-like structure 73. The sensor 71 may optionally include a luerlock hub 81 for attachment to a syringe for adding or removing fluidincluding antibiotic or antimicrobial.

[0043] Another method of the invention comprises the steps of:implanting the inflatable penile prosthesis system 10 in a patient;providing a probe assembly with first and second sensors; placing thefirst sensor through the septum and into the fluid circuit of theinflatable penile prosthesis system; placing a second sensor outside thepenile prosthesis system in the patient's tissue, sensing conditionswith the first and second sensors, and comparing the conditions sensedby the first and second sensors to detect an unsatisfactory condition.The unsatisfactory condition may comprise fluid leakage or infection.The first and second sensors may be capable of sensing pH, electricalresistance or electrical potential.

[0044] Referring to FIG. 9, in one embodiment, a probe system 100 maycomprise an ohmmeter 102. First and second sensors are shown in FIG. 9.

[0045] In another embodiment, at least one of the first and secondsensors is integrated into the inflatable penile prosthesis system, andthe probe system includes means for communicating with the sensorintegrated into the inflatable penile prosthesis system. For example,the means for communicating with the sensor may include a probe forestablishing electrical contact with the sensor. Alternatively, themeans may comprise remote sensors such as pressure switches, ormagnetostrictive ferromagnetic materials. For example, magnetostrictiveand ferromagnetic materials an remote interrogation mechanisms aredisclosed in U.S. Pat. No. 5,745,039.

[0046] A septum may also be used to test for unsatisfactory conditionsassociated with a device (e.g. leakage) through electrical conductivitytesting or refilling the device with radio-opaque solutions where thedevice was originally filled with saline. The electrical conductivitytesting could be accomplished through the use of a polymer-coated needlesuch as the needle 71. The polymer coating 77 provides insulation to thetissues being punctured, while the shaft 73 of the needle provides theelectrical path to the center of the device. Needle designs or electrodepatches that create the remaining part of the circuit may be used. Totest for an infection (e.g. inside the prosthesis), a surgeon could passa needle 71 through the skin and through the septum 20 and withdrawfluid for culturing. Later, with another needle pierce, the surgeoncould inject the appropriate amount of antibiotic. Alternatively, theantibiotic may be injected prophylactically prior to culturing. Thefluid pressure within the system may optionally be monitored.

[0047]FIG. 8 illustrates the needle 71 puncturing septum 20. This placesthe needlelike sensor 71 into the prosthesis with the tip fo the probecommunicating with the interior of the prosthesis.

[0048] In another aspect, the present invention comprises the step ofusing a penile prosthesis to generate elongation in penile corporallength of original implant or on revision implants. The ability to havea penile prosthesis that can expand in girth and length has beendemonstrated in product literature. However, the present inventioncomprises the novel steps of placing a septum on a penile device andcombining it with cylinders that expand in length and girth. The methodcan create a lengthening in penile shaft length through tissue modelingor tissue engineering. This may have application for plastic surgery forthe creation or restoration of a phallus in cases of severe trauma,penile cancer or ambiguous genitalia.

[0049] The present invention also comprises a method of treatingcorporal shortening normally seen following removals of the implant. Inanother aspect, the present invention comprises treating patients whohave had device removals (e.g. due to infections) where a new device isnot or cannot immediately be implanted, or by patient or physicianpreference is not implanted. An unsatisfactory condition to implant atthe time of revision surgery may result in subsequent scarring andshortening of penile shaft length. Upon revision surgery, the physiciancan normally place a cylinder of smaller diameter than originallyimplanted often the rear tip of the prosthesis requires a so called“narrow base” implant. What is disclosed is the capability of now usinga “narrow base prosthesis” with elongation capability to regain lostcorporal length.

[0050] Several surgical methods are contemplated herein. A variety ofdifferent surgical approaches are contemplated herein includinginfrapubic and penoscrotal approaches. Such procedures are disclosed,for example, in the Operating Room Manual for the AMS 700™ PenileProsthesis, available from American Medical Systems of Minnetonka,Minn., ©2001.

[0051] All patents, patent applications, and publications cited hereinare hereby incorporated by reference in their entirety as ifindividually incorporated.

[0052] The present invention has now been described with reference toseveral embodiments. The foregoing detailed description and exampleshave been given for clarity of understanding only. Those skilled in theart will recognize that many changes can be made in the describedembodiments without departing from the scope and spirit of theinvention. Thus, the scope of the present invention should not belimited to the exact details and structures described herein, but ratherby the appended claims and equivalents.

What is claimed is:
 1. A method of restoring erectile function comprising the steps of: providing an inflatable penile prosthesis system comprising a pump, a cylinder capable of inflated and deflated states, a septum and a reservoir capable of inflated and deflated states, providing sufficient fluid to inflate the cylinder and the reservoir to the inflated condition; implanting the inflatable penile prosthesis system with the cylinder and reservoir in the inflated condition; leaving the cylinder and reservoir in the inflated condition in the immediate post operative period, and thereafter inserting a needle through the septum and withdrawing some fluid from the inflatable penile prosthesis system.
 2. A method according to claim 1 where in the step of leaving the cylinder and reservoir in the inflated condition in the immediate post operative period includes the step of leaving the cylinder and reservoir in the inflated condition for at least three days.
 3. A method of detecting an unsatisfactory condition of an inflatable penile prosthesis system comprising a pump, a cylinder, fluid circuit, a septum and a reservoir, the method comprising the steps of: implanting the inflatable penile prosthesis system in a patient; providing a probe assembly with first and second sensors; placing the first sensor through the septum and into the fluid circuit of the inflatable penile prosthesis system; placing a second sensor outside the penile prosthesis system in the patient's tissue, sensing conditions with the first and second sensors, and comparing the conditions sensed by the first and second sensors to detect an unsatisfactory condition.
 4. A method according to claim 3 wherein the unsatisfactory condition is fluid leakage.
 5. A method according to claim 3 wherein the unsatisfactory condition is infection.
 6. A method according to claim 3 wherein the first and second sensors are capable of sensing pH.
 7. A method according to claim 3 wherein the first and second sensors are capable of sensing electrical potential and the probe system comprises an ohmmeter.
 8. A method according to claim 3 wherein the first and second sensors are capable of sensing resistance.
 9. A method according to claim 3 wherein at least one of the first and second sensors is integrated into the inflatable penile prosthesis system, and the probe system includes means for communicating with the sensor integrated into the inflatable penile prosthesis system.
 10. A system for restoring erectile function comprising: a pump, a cylinder, tubing and a reservoir, a fluid circuit within the system containing fluid, a septum, and an antimicrobial or antibiotic within the fluid placed by inserting a needle through the septum and injecting the antimicrobial or antibiotic.
 11. A system for restoring erectile function according to claim 10 wherein the antimicrobial or antibiotic comprises rifampin and minocycline.
 12. A system for restoring erectile function according to claim 10 wherein the antimicrobial comprises an iodine containing compound.
 13. A method of restoring erectile function comprising the steps of: implanting an inflatable penile prosthesis having fluid and a septum, placing a needle through the septum, and injecting an antimicrobial through the septum and into the prosthesis.
 14. A method according to claim 13 wherein the prosthesis comprises a cylinder comprising silicone, and the antimicrobial comprises iodine.
 15. A method according to claim 13 further including the step of aspirating fluid from the inflatable penile prosthesis prior to the step of injecting an antimicrobial.
 16. A method according to claim 13 wherein the antibiotic solution is infused.
 17. A method according to claim 13 wherein the antibiotic or antimicrobial solution subsequently diffuses through the prosthesis.
 18. A method according to claim 17 wherein the step of implanting a prosthesis includes the step of implanting a prosthesis constructed at least in part of silicone and the step of diffusing an antibiotic or antimicrobial includes the step of diffusing iodine. 